Otitis Media With Effusion Clinical Trial
Official title:
Comparison of Three Methods Used in the Diagnosis of Extraesophageal Reflux in Children With Chronic Otitis Media With Effusion
Detection of extraesophageal reflux (EER) in children with chronic otitis media with effusion (OME) using three different diagnostic methods and selection of the group of patients with severe EER who could potentially benefit from antireflux therapy.
Children aged between 1 and 7 years diagnosed with bilateral or unilateral OME who underwent
adenoidectomy and myringotomy with insertion of a ventilation tube were included in the
prospective study. OME was defined as effusion in the middle ear behind an intact eardrum
for longer than 3 months. Diagnosis was made on the basis of otomicroscopic findings,
pneumatic otoscopy, type B tympanometry and audiometry (in older, cooperative children).
Children with no fluid in the middle ear during myringotomy were re-diagnosed as having
tympanosclerosis and were excluded from the study. Children with craniofacial abnormalities
(Down syndrome, Treacher Collins syndrome, clefts etc.) were excluded from the study as
well. Demographic data and symptoms of EER disease were provided by parents, who were
specifically asked about hoarseness, recurrent lower respiratory infections (bronchitis,
pneumonia) and bronchial asthma in their child.
24 hour monitoring of oropharyngeal pH using the Restech system was performed before
surgery. Parents were instructed to record the time their child spent eating, drinking and
in a horizontal position directly to the device and manually to the diary. If there was any
discrepancy, periods logged in the device were modified according to the diary. A
standardized RYAN composite score was calculated automatically using the software supplied.
Patients with pathological RYAN composite scores in the vertical (higher than 9.4) and/or
horizontal (higher than 6.8) position were classified as having pathological EER. Severe EER
was diagnosed when the RYAN composite score in the vertical or horizontal position was
higher than 200.
Myringotomy using a microscope was done on the anterior inferior part of the tympanic
membrane. The type of middle ear effusion (fluid, mucous) was registered. Middle ear fluid
was collected using a special suction device with a collecting bottle, and a ventilation
tube was inserted in the tympanic membrane. In the case of bilateral OME, middle ear fluids
were collected and analysed separately. The specimen was first standardized. 0.1 ml of 10%
citric acid was added, the specimen was centrifuged for 10 minutes and subsequently the
original migration reagent was added. Afterwards, the specimen was examined using Peptest,
which contains monoclonal antibodies that target pepsin. The result of the Peptest was given
as positive (2 lines), negative (1 line) or invalid (no line).
Then, adenoidectomy using a cold instrument was performed. A specimen of adenoids (5x5x5mm)
from the area close to the torus tubarius was fixed in formaldehyde and
immunohistochemically analysed at the Department of Pathology. Antibody P3635Rb-h (Uscnlife,
USA, concentration 1:100) was used as the primary antibody. Antibody N-HistofineSimple Stain
MAX PO (Nichirei Biosciences Inc.) was used as the secondary antibody.
Statistical analysis was done using MS Excel.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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